Long-term efficacy and safety of lamotrigine monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures: An open-label extension study.

PURPOSE: To investigate the efficacy and safety of long-term lamotrigine (LTG) monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures. METHODS: Six Japanese patients and one South Korean patient were enrolled in the extension phase of the study after completing the 12-week maintenance phase of an open-label clinical study of LTG monotherapy. During the extension phase, patients underwent efficacy and safety evaluation every 12 weeks. RESULTS: Of the seven patients, six patients completed the extension phase. The seizure-free rate confirmed by hyperventilation (HV)-electroencephalography ranged from 71.4% to 100.0% at each visit up to Week 168 of the extension phase. Similar effects were confirmed by HV-clinical signs and seizure diaries. Although no unexpected adverse events were observed, one Japanese patient was withdrawn from the extension phase due to mild drug-related rash developed 842 days after the start of LTG. CONCLUSION: Although the number of patients is limited, long-term LTG monotherapy appeared to be effective and generally well tolerated in Japanese and South Korean pediatric patients with typical absence seizures.

Lamotrigine monotherapy for newly diagnosed typical absence seizures in children: A multi-center, uncontrolled, open-label study.

PURPOSE: To evaluate the efficacy and safety of lamotrigine (LTG) monotherapy for treating Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures. METHODS: Twenty patients with newly diagnosed typical absence seizures aged 4-12 years were enrolled in the study and were administered LTG at an initial dose of 0.3 mg/kg/day for 2 weeks, followed by 0.6 mg/kg/day for an additional 2 weeks. Thereafter, the dose was increased by 0.6 mg/kg/day up to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was the lower dose) until patients were confirmed to be seizure free induced by hyperventilation (HV). After confirmation, the dose was increased by one level (0.6 mg/kg/day). If the patient was found to be seizure free by HV-electroencephalography (EEG) on the following two consecutive visits, the patient entered the 12-week maintenance phase. After the maintenance phase, patients could enter the extension phase if clinically indicated. RESULTS: The seizure-free rate confirmed by HV-EEG at the end of the maintenance phase was 35.0% (7/20 patients). Most of patients who were confirmed to be seizure free during the escalation phase had maintained seizure control during the 12-week maintenance phase and the 12-week extension phase. The most frequently noted adverse events were bronchitis, headache, and rash (20% each). No serious adverse events were reported. CONCLUSION: Lamotrigine monotherapy in Japanese and South Korean children with typical absence seizures was well tolerated and 35.0% of patients were seizure free at the end of maintenance phase.

Two new cucurbitacin glucosides, opercurins A and B, from the Brazilian folk medicine "Buchinha" (Luffa operculata).

The structures of two new cucurbitacin glucosides designated opercurins A (1) and B (2), isolated from the fruit of Luffa operculata, have been confirmed by extensive spectroscopic investigation.